Pharmacokinetics and Safety of AmBisome and DKF-5122
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: 1A(RT) Patients (AmBisome, DKF-5122) |
Drug: AmBisome
Reference, dose of 3 mg/kg.
Drug: DKF-5122
Test, dose of 3 mg/kg
|
Other: 1B(TR) Patients (DKF-5122, AmBisome) |
Drug: AmBisome
Reference, dose of 3 mg/kg.
Drug: DKF-5122
Test, dose of 3 mg/kg
|
Other: 2A(RT) Healthy subjects (AmBisome, DKF-5122) |
Drug: AmBisome
Reference, dose of 3 mg/kg.
Drug: DKF-5122
Test, dose of 3 mg/kg
|
Other: 2B(TR) Healthy subjects (DKF-5122, AmBisome) |
Drug: AmBisome
Reference, dose of 3 mg/kg.
Drug: DKF-5122
Test, dose of 3 mg/kg
|
Outcome Measures
Primary Outcome Measures
- Cmax [0 to 93 hr]
Liposome encapsulated amphotericin B of healthy adult
- AUClast [0 to 93 hr]
Liposome encapsulated amphotericin B of healthy adult
Secondary Outcome Measures
- Cmax [0 to 93 hr]
Unbound Amphotericin B of healthy adult
- AUClast [0 to 93 hr]
Unbound Amphotericin B of healthy adult
- AUCinf [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
- tmax [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
- t1/2 [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
- CL/F [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
- V/F [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult
- Cmin,ss [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- Cav,ss [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- tmax,ss [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- t1/2 [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- PTF (peak to trough fluctuation ratio) [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- CLss/F [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
- Vd,ss/F [0 to 93 hr]
Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient
Eligibility Criteria
Criteria
Inclusion Criteria:
- Part 1. Patients
-
Age 19 years and older
-
Empirical therapy for presumed fungal infection in febrile, neutropenic patients
-
Voluntarily decided to participate in the study and signed the informed consent form
-
Having contraception during the study
- Part 2. Healthy subjects
-
Age 19 to 45 years
-
Body weight 55 kg or more, within ±20% of the ideal body weight
-
Having no congenital or chronic disease within the last 5 years.
-
Voluntarily decided to participate in the study and signed the informed consent form
-
Having contraception during the study
Exclusion Criteria:
- Part 1. Patients
-
Clinically significant conditions that may affect the pharmacokinetics of amphotericin
-
History of diseases that may affect the pharmacokinetics of amphotericin
-
History of drug abuse
-
History of hypersensitivity to ingredients of investigational products
-
Unable to maintain proper contraception
-
Pregnant or breast-feeding
-
The following laboratory test results at screening
-
Hemoglobin < 8.0 g/dL
-
Serum Creatinine > 2x the UNL
-
AST or ALT > 10x UNL
-
Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg
-
Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg
- Before the first administration of investigational products
-
Participation to other clinical trials within 6 months
-
Whole blood donation within 60 days or component within 30 days
-
(Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days
-
Grapefruit-containing foods within 7 days
-
Excessive exercise within 7 days
-
Excessive caffeine and alcohol consumption, or a smoker
-
Not eligible due to other reasons at the investigator's discretion
- Part 2. Healthy subjects
-
Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
-
Clinically significant conditions that may affect the pharmacokinetics of amphotericin
-
History of diseases that may affect the pharmacokinetics of amphotericin
-
History of drug abuse
-
History of hypersensitivity to ingredients of investigational products
-
Unable to maintain proper contraception
-
Pregnant or breast-feeding
-
The following laboratory test results at screening
-
Hemoglobin < 13.0 g/dL
-
Serum Creatinine > 1.25 x UNL
-
eGFR < 90 mL/min/1.73 m2
-
AST or ALT > 1.25 x UNL
-
Total bilirubin > 1.25 x UNL
-
CPK > 1.5 x UNL
-
Systolic blood pressure ≥140 mmHg or ≤90 mmHg
-
Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg
-
Arrhythmia
- Before the first administration of investigational products
-
Participation to other clinical trials within 6 months
-
Whole blood donation within 60 days or component within 30 days
-
Drugs that induce or inhibit drug metabolism enzymes within 30 days
-
Vaccination within 7 days
-
Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days
-
Grapefruit-containing foods within 7 days
-
Excessive exercise within 7 days
-
Excessive caffeine and alcohol consumption, or a smoker
-
Not eligible due to other reasons at the investigator's discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | Seocho-gu | Korea, Republic of | 06591 |
Sponsors and Collaborators
- Dongkook Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DKF-5122-BE